Utak Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Utak Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2022375
FEI Number2022375
NameUTAK LABORATORIES, INC.
Owner & OperatorUTAK LABORATORIES, I
Contact Address25020 AVENUE TIBBITTS --
Valencia CA 91355 US
Official Correspondent
  • Kevin M Kopp
  • x-661-2943935-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address25020 AVENUE TIBBITTS
VALENCIA, CA 91355 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
UTAK LABORATORIES, INC.
MYCOPHENOLIC ACID GLUCURONIDE LEVEL 4 MPAG 4 S MAYO2024-02-29
UTAK LABORATORIES, INC.
MYCOPHENOLIC ACID GLUCURONIDE LEVEL 2 MPAG 2 S MAYO2024-02-29
UTAK LABORATORIES, INC.
MYCOPHENOLIC ACID LEVEL 5 MPA 5 S MAYO2024-02-29
UTAK LABORATORIES, INC.
MYCOPHENOLIC ACID LEVEL 3 MPA 3 S MAYO2024-02-29
UTAK LABORATORIES, INC.
MYCOPHENOLIC ACID LEVEL 1 MPA 1 S MAYO2024-02-29
UTAK LABORATORIES, INC.
GABAPENTIN LEVEL 3 V2 GABA 3 V2 SMXU F PG2024-02-29
UTAK LABORATORIES, INC.
GABAPENTIN LEVEL 1 V2 GABA 1 V2 SMXU F PG2024-02-29
UTAK LABORATORIES, INC.
COTININE PLUS LEVEL 1 V2 COT+ 1 V2 S LC2024-02-29
UTAK LABORATORIES, INC.
ANABASINE PLUS LEVEL 2 V2 ANAB+ 2 V2 U LC2024-02-29
UTAK LABORATORIES, INC.
ANABASINE PLUS LEVEL 1 V2 ANAB+ 1 V2 U LC2024-02-29
UTAK LABORATORIES, INC.
TRACE ELEMENTS QC LEVEL 1 V2 TRACE QC 1 V2 S PAML2024-02-28
UTAK LABORATORIES, INC.
INFLIXIMAB LEVEL 3 INFLIX QC 3 UPHS2024-02-28
UTAK LABORATORIES, INC.
INFLIXIMAB LEVEL 2 INFLIX QC 2 UPHS2024-02-28
UTAK LABORATORIES, INC.
INFLIXIMAB LEVEL 1 INFLIX QC 1 UPHS2024-02-28
UTAK LABORATORIES, INC.
BUSULFAN QC LEVEL 2 BUS QC 2 P F URMC 2024-02-28
UTAK LABORATORIES, INC.
BUSULFAN QC LEVEL 1 BUS QC 1 P F URMC2024-02-28
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR 4 BUS CAL 4 P F URMC 2024-02-28
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR 3 BUS CAL 3 P F URMC2024-02-28
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR 2 BUS CAL 2 P F URMC 2024-02-28
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR 1 BUS CAL 1 P F URMC 2024-02-28
UTAK LABORATORIES, INC.
CERTIFIED DRUG FREE URINE 88121-CDF(L)LTR WVDTL2024-02-28
UTAK LABORATORIES, INC.
THC PLUS LEVEL 4 V2 THC+ 4 U V2 NJSP2024-02-26
UTAK LABORATORIES, INC.
THC PLUS LEVEL 3 V2 THC+ 3 U V2 NJSP2024-02-26
UTAK LABORATORIES, INC.
BSIM QC BSIM QC2024-02-26
UTAK LABORATORIES, INC.
BASIC QC BASIC QC2024-02-26
UTAK LABORATORIES, INC.
ACID-NEUT QC ACID-NEUT QC2024-02-26
UTAK LABORATORIES, INC.
TRACE ELEMENTS QC LEVEL 3 TRACE QC 3 S PAML2024-02-23
UTAK LABORATORIES, INC.
TRACE ELEMENTS QC LEVEL 2 TRACE QC 2 S PAML2024-02-23
UTAK LABORATORIES, INC.
TRACE ELEMENTS QC LEVEL 1 TRACE QC 1 S PAML2024-02-23
UTAK LABORATORIES, INC.
SMA QC SMA QC2024-02-23
UTAK LABORATORIES, INC.
IODINE QC LEVEL 3 IOD QC 3 U QDVA2024-02-23
UTAK LABORATORIES, INC.
IODINE QC LEVEL 2 IOD QC 2 U QDVA2024-02-23
UTAK LABORATORIES, INC.
IODINE QC LEVEL 1 IOD QC 1 U QDVA2024-02-23
UTAK LABORATORIES, INC.
AMIODARONE LEVEL 2 AMIO 2 S F QDVA2024-02-23
UTAK LABORATORIES, INC.
AMIODARONE LEVEL 1 AMIO 1 S F QDVA2024-02-23
UTAK LABORATORIES, INC.
TCA QC TCA QC2024-02-22
UTAK LABORATORIES, INC.
VOLATILES VOL U CCL2024-02-20
UTAK LABORATORIES, INC.
EVEROLIMUS 8 NG/ML EVER 8 WB F UCSF 2024-02-20
UTAK LABORATORIES, INC.
EVEROLIMUS 18 NG/ML EVER 18 WB F UCSF2024-02-20
UTAK LABORATORIES, INC.
ETG PLUS QC LEVEL 3 V2 ETG+ QC 3 V2 U F UCSF2024-02-20
UTAK LABORATORIES, INC.
ETG PLUS QC LEVEL 2 V2 ETG+ QC 2 V2 U F UCSF2024-02-20
UTAK LABORATORIES, INC.
ETG PLUS QC LEVEL 1 V2 ETG+ QC 1 V2 U F UCSF2024-02-20
UTAK LABORATORIES, INC.
ETG PLUS CALIBRATOR LEVEL 6 ETG+ CAL 6 V2 U F UCSF2024-02-20
UTAK LABORATORIES, INC.
ETG PLUS CALIBRATOR LEVEL 5 ETG+ CAL 5 V2 U F UCSF2024-02-20
UTAK LABORATORIES, INC.
ETG PLUS CALIBRATOR LEVEL 4 ETG+ CAL 4 V2 U F UCSF2024-02-20
UTAK LABORATORIES, INC.
ETG PLUS CALIBRATOR LEVEL 3 ETG+ CAL 3 V2 U F UCSF2024-02-20
UTAK LABORATORIES, INC.
ETG PLUS CALIBRATOR LEVEL 2 ETG+ CAL 2 V2 U F UCSF2024-02-20
UTAK LABORATORIES, INC.
ETG PLUS CALIBRATOR LEVEL 1 ETG+ CAL 1 V2 U F UCSF2024-02-20
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 1 V2 DAU 2 V2 F SNC2024-02-20
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 1 V2 DAU 1 V2 F SNC2024-02-20
UTAK LABORATORIES, INC.
FENTANYL PLUS LEVEL 4 FENT+ 4 V2 U NJSP2024-02-16
UTAK LABORATORIES, INC.
FENTANYL PLUS LEVEL 3 FENT+ 3 V2 U NJSP2024-02-16
UTAK LABORATORIES, INC.
AMITRIPTYLINE PLUS LEVEL 2 AMIT+ 2 F DW ECME2024-02-16
UTAK LABORATORIES, INC.
ACETONE BLANK ACE BLK S F BSRHS2024-02-16
UTAK LABORATORIES, INC.
LEAD 2.5 UG/DL LEAD 2.5 WB ACL2024-02-14
UTAK LABORATORIES, INC.
POSITIVE CONTROL POS CON 50 WB F EBS2024-02-13
UTAK LABORATORIES, INC.
NEGATIVE CONTROL NEG CON 150 WB F EBS2024-02-13
UTAK LABORATORIES, INC.
ESTRONE PLUS 400 PG/ML ESTRO+ 400 S F BRL2024-02-13
UTAK LABORATORIES, INC.
ESTRONE PLUS 25 PG/ML ESTRO+ 25 S F BRL2024-02-13
UTAK LABORATORIES, INC.
ESTRONE PLUS 150 PG/ML ESTRO+ 150 S F BRL2024-02-13
UTAK LABORATORIES, INC.
DAUPOSFUVHS DAU POS F UVHS2024-02-13
UTAK LABORATORIES, INC.
DAUNEGFUVHS DAU NEG F UVHS2024-02-13
UTAK LABORATORIES, INC.
CERTIFIED DRUG FREE URINE 100 ML 88121-CDF(L)100 MM2024-02-13
UTAK LABORATORIES, INC.
AMPHETAMINE PLUS LEVEL 2 AMPH+ 2 U V3 F WBH2024-02-12
UTAK LABORATORIES, INC.
AMPHETAMINE PLUS LEVEL 1 AMPH+ 1 U V3 F WBH2024-02-12
UTAK LABORATORIES, INC.
LORAZEPAM GLUCURONIDE 620 NG/ML LORAZ GLUC 620 U F UCSD2024-02-09
UTAK LABORATORIES, INC.
VOLATILES 40 MG/DL VOL 40 WB F UM2024-02-08
UTAK LABORATORIES, INC.
OPIATES LEVEL 3 V2 OPAT L3 V2 MAYO2024-02-08
UTAK LABORATORIES, INC.
OPIATES LEVEL 2 V2 OPAT L2 V2 MAYO2024-02-08
UTAK LABORATORIES, INC.
IMMUNOSUPPRESSANTS LEVEL 2 IMMUNOS 2 WB F ARUP2024-02-08
UTAK LABORATORIES, INC.
IMMUNOSUPPRESSANTS LEVEL 1 IMMUNOS 1 WB F ARUP2024-02-08
UTAK LABORATORIES, INC.
ETHANOL 250 MG/DL ETH 250 WB F UM2024-02-08
UTAK LABORATORIES, INC.
OPIATES MID OPIA MID U UNC2024-02-07
UTAK LABORATORIES, INC.
OPIATES LOW OPIA LOW U UNC2024-02-07
UTAK LABORATORIES, INC.
OPIATES HIGH OPIA HIGH U UNC2024-02-07
UTAK LABORATORIES, INC.
TCA PANEL TCA U F NMS2024-02-06
UTAK LABORATORIES, INC.
SULFAMETHOXAZOLE PLUS LEVEL 23 SUL+ 3 V3 MAYO2024-02-06
UTAK LABORATORIES, INC.
SULFAMETHOXAZOLE PLUS LEVEL 2 SUL+ 2 V3 MAYO2024-02-06
UTAK LABORATORIES, INC.
SULFAMETHOXAZOLE PLUS LEVEL 1 SUL+ 1 V3 MAYO2024-02-06
UTAK LABORATORIES, INC.
PSYCH URINE V3 CALIBRATOR PSY UR V3 CAL2024-02-06
UTAK LABORATORIES, INC.
ETHANOL 80 MG/DL ETH 80 WB KCCL2024-02-06
UTAK LABORATORIES, INC.
TESTOSTERONE 250 NMOL/L TESTO 250 S F BD2024-02-05
UTAK LABORATORIES, INC.
TOTAL PSA 400 NG/ML PSA 400 S F BD2024-02-05
UTAK LABORATORIES, INC.
FENTANYL FENT UF DH 2024-02-05
UTAK LABORATORIES, INC.
CORTISOL 7000 NMOL/L CORT 7000 S F BD2024-02-05
UTAK LABORATORIES, INC.
BARBITURATES PLUS LEVEL 2 BARBS+ 2 U V F RDL2024-02-02
UTAK LABORATORIES, INC.
BARBITURATES PLUS LEVEL 1 BARBS+ 1 U V F RDL 2024-02-02
UTAK LABORATORIES, INC.
ANTIFUNGALS LEVEL 3 A-FUNG L3 S F UW2024-02-02
UTAK LABORATORIES, INC.
ANTIFUNGALS LEVEL 2 A-FUNG L2 S F UW2024-02-02
UTAK LABORATORIES, INC.
ANTIFUNGALS LEVEL 1 A-FUNG L1 S F UW2024-02-02
UTAK LABORATORIES, INC.
TOX I_05 24 TOX I_05 242024-02-01
UTAK LABORATORIES, INC.
TOX I_04 24 TOX I_04 242024-02-01
UTAK LABORATORIES, INC.
TOX I_03 24 TOX I_03 242024-02-01
UTAK LABORATORIES, INC.
TOX I_02 24 TOX I_02 242024-02-01
UTAK LABORATORIES, INC.
TOX I_01 24 TOX I_01 242024-02-01
UTAK LABORATORIES, INC.
DEXTRORPHAN PLUS DEXT+ U F KFR2024-02-01
UTAK LABORATORIES, INC.
BUSULFAN QC LEVEL 3 BUS QC 3 F SHP BHM2024-01-30
UTAK LABORATORIES, INC.
BUSULFAN QC LEVEL 2 BUS QC 2 F SHP BHM2024-01-30
UTAK LABORATORIES, INC.
ANTICONVULSANTS MR ANTI MR UPMC2024-01-30
UTAK LABORATORIES, INC.
NTICONVULSANTS HR ANTI HR UPMC2024-01-30
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Vi2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Li Tx Control2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Whole Blood Lead Controls2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Trace Elements Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Clonazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK STABBS Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Vancomycin Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Benzodiazepines Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Flurazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Disopyramide Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Pentobarbital Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Caffeine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Maprotiline Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Amoxapine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Salicylate Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Acetaminophen Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Barbiturates Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs II Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs I Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Anticonvulsants Control2007-12-05
UTAK LABORATORIES, INC.
UTAK LABORATORIES TOXICOLOGY CONTROL1991-04-12
UTAK LABORATORIES, INC.
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL1988-10-06
UTAK LABORATORIES, INC.
SERUM VANCOMYCIN TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
BENZODIAZEPINES TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
SERUM CLONAZEPAM TOXICOLOGY CONTROL1986-11-05
UTAK LABORATORIES, INC.
UTAK-STABBS TOXICOLOGY CONTROL1986-08-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS1983-07-28
UTAK LABORATORIES, INC.
FLURAZEPAM TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
CAFFINE TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
MAPROTILINE1983-07-26
UTAK LABORATORIES, INC.
AMOXAPINE 8-HYDRO-XYAMOXAPINE1983-07-26
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSNATS VI1983-07-19
UTAK LABORATORIES, INC.
DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE1983-07-06
UTAK LABORATORIES, INC.
PENTOBARBITAL TOXICOLOGY CONTROL1983-07-06
UTAK LABORATORIES, INC.
TOXICOLOGY CONTROL1981-02-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL1980-05-02
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANT II TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS SALICYLATE TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
BARBITURATES TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS II TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS I TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
ANTICONVULSANTS TOXICOLOGY CONTROL1980-04-29

Related Finance Registrations

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.